Longitudinal Study of Music Therapy's Effectiveness for Premature Infants and Their Caregivers
- Conditions
- Preterm Birth
- Interventions
- Behavioral: MT during NICUOther: Standard careBehavioral: MT after NICU
- Registration Number
- NCT03564184
- Lead Sponsor
- NORCE Norwegian Research Centre AS
- Brief Summary
Background: Preterm birth has major medical, psychological and socio-economic consequences worldwide. A recent systematic review suggests positive effects of music therapy (MT) on physiological measures of preterm infants and maternal anxiety, but methodologically rigorous studies including long-term follow-up of infant and parental outcomes are missing. Drawing upon caregivers' inherent resources, this study emphasizes caregiver involvement in MT to promote attuned, developmentally-appropriate musical interactions that may be of mutual benefit to infant and parent. This study will determine whether MT, as delivered by a qualified music therapist during neonatal intensive care unit (NICU) hospitalization and/or in home/municipal settings following discharge, is superior to standard care in improving bonding between primary caregivers and preterm infants, parent well-being and infant development.
Methods: Design: International multi-center, assessor-blind, 2x2 factorial, pragmatic randomized controlled trial. A feasibility study has been completed; ethical approval for the main trial is pending. Participants: 250 preterm infants and their parents. Intervention: MT focusing on singing specifically tailored to infant responses, will be delivered during NICU and/or during a post-discharge 6-month period. Primary outcome: Changes in mother-infant bonding until 6 months corrected age (CA), as measured by the Postpartum Bonding Questionnaire. Secondary outcomes: Mother-infant bonding at discharge and over 12 months CA; child development over 24 months; and parental depression, anxiety, and stress, and infant re-hospitalization, all over 12 months.
Discussion: This study fills a gap by measuring the long-term impact of MT for preterm infants/caregivers, and of MT beyond the hospital context. Outcomes related to highly involving parents in MT will directly inform the development of clinical practice in Scandinavia and other contexts with similar social welfare practices. By incorporating family-centered care, continuity of care, user involvement, and cultural relevance, this study can potentially contribute to improved quality of care for premature infants and their parents worldwide.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 213
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description MT during NICU Standard care Consists of music therapy during NICU hospitalization, along with standard care. MT during and after NICU Standard care Consists of music therapy during NICU hospitalization, and music therapy after discharge from initial NICU hospitalization, along with standard care. MT during NICU MT during NICU Consists of music therapy during NICU hospitalization, along with standard care. No MT Standard care Consists of standard care. MT during and after NICU MT during NICU Consists of music therapy during NICU hospitalization, and music therapy after discharge from initial NICU hospitalization, along with standard care. MT during and after NICU MT after NICU Consists of music therapy during NICU hospitalization, and music therapy after discharge from initial NICU hospitalization, along with standard care. MT after NICU MT after NICU Consists of music therapy after discharge from initial NICU hospitalization, along with standard care. MT after NICU Standard care Consists of music therapy after discharge from initial NICU hospitalization, along with standard care.
- Primary Outcome Measures
Name Time Method Bonding between primary caregiver and infant 6 months Total score of the Postpartum Bonding Questionnaire (PBQ), a parent-rated screening instrument for disorders of the early mother-infant relationship consisting of 25 statements on a six-point Likert scale (each 0-5; sum score ranging from 0 to 125; high = problematic).
- Secondary Outcome Measures
Name Time Method Infant development 12 months Ages and Stages Questionnaire, 3rd edition (ASQ-3), an age-specific parent-reported screening questionnaire consisting of 30 items, total sum score ranging from 0 to 300, with higher scores indicating better development.
Bonding between primary caregiver and infant 12 months Total score of the Postpartum Bonding Questionnaire (PBQ), a parent-rated screening instrument for disorders of the early mother-infant relationship consisting of 25 statements on a six-point Likert scale (each 0-5; sum score ranging from 0 to 125; high = problematic).
Infant socio-emotional development 12 months Ages and Stages Questionnaire Social-Emotional (ASQ:SE), a parent-completed questionnaire with 19 or 22 Likert-scaled items (each 0-5-10), plus additional items for whether an item is of concern to the parent (each 0-5), resulting in a score ranging from 0-285 or 0-300, at 6 and 12 months respectively. Lower scores indicate better socio-emotional development.
Parental stress 12 months Parental Stress Scale (PSS), a self-report 18-item questionnaire that assesses stress associated with parenting. Sum scores can range from 18 to 90, with higher scores indicating higher stress.
Parental anxiety 12 months Generalized Anxiety Disorder Assessment (GAD-7), a self-report 7-item questionnaire serving as a screening tool and severity measure for generalized anxiety disorder. Sum scores can range from 0 to 21, with higher scores indicating higher anxiety.
Child development 24 months Bayley Scales of Infant and Toddler Development, 3rd edition (Bayley-III), standardized with a population mean of 100 (SD 15), with higher scores indicating better development
Re-hospitalization 12 months Re-hospitalization excluding outpatient visits, based on electronic health records. This will be calculated as the time from initial discharge until first re-hospitalization.
Maternal depression 12 months Edinburgh Postnatal Depression Scale (EPDS), a 10-item validated self-report instrument assessing mothers' postpartum depressive symptoms, excluding somatic symptoms of depression that are common in new mothers (such as loss of energy, feeling tired, changes in appetite and sexual drive). Sum scores can range from 0 to 30, with high scores indicating more depressive symptoms.
Trial Locations
- Locations (10)
Hospital Materno Infantil Ramón Sardá
🇦🇷Buenos Aires, Caba, Argentina
Sanatorio Mater Dei
🇦🇷Buenos Aires, Caba, Argentina
Clinica de la Mujer
🇨🇴Bogotá, Colombia
Hospital Fernandez
🇦🇷Buenos Aires, Argentina
Fundación Santa Fe de Bogotá
🇨🇴Bogotá, Colombia
Haukeland University Hospital, Barne-og ungdomsklinikken
🇳🇴Bergen, Hordaland, Norway
Akershus University Hospital
🇳🇴Oslo, Lørenskog, Norway
Meir Medical Center
🇮🇱Kfar Saba, Israel
Oslo University Hospital, Rikshospitalet
🇳🇴Oslo, Norway
Szpital Miejski w Rudzie Śląskiej
🇵🇱Ruda Śląska, Poland